Summary:    

Ensure daily material planning and manufacturing activities for RBX2660 and other Rebiotix clinical and development drug products are completed.

Responsibilities:

• Follow cGMP requirements- ensure all manufacturing activities are performed following written procedures and report infractions to Manager


• Prepare production and daily/weekly personnel work schedules in coordination with the Manager


• Plan cleaning, manufacturing, and documentation activities in a manner that maximizes efficiency


• Ensure released inventory remains at target quality and inventory levels


• Lead, direct and participate in manufacturing operations including donation/DHS collection, drug substance manufacturing, and cleaning activities


• Ensure production areas are kept in a neat and orderly state


• Communicate daily production activities and performance against targets to the Manufacturing Manager


• Monitor production activities for issues or concerns, communicate issues or concerns promptly to the Manufacturing Manager


• Create or modify technical documents to meet new or revised requirements


• Generate monthly performance metrics for the manufacturing area

Requirements:

• 3+ years GMP Pharmaceutical experience


• Experience with manufacturing processes


• Capsule Manufacturing experience preferred


• cGMP manufacturing experience


• Experience in a controlled, regulated work environment


• Must have excellent communications skills


• Experience with technical documents and technical reports


• Must be detailed oriented and able to follow specific work instructions


• Must be able to accurately perform calculations per batch records

We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.